Practix Convenio Mobile X-ray System 의 안전성 경고

Safety alert

2012-05-31

2012-05-31

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120531.html

Medical device safety alert: philips practix convenio mobile x-ray system medical device manufacturer, philips medical systems issued a safety alert concerning practix convenio mobile x-ray system with serial number pc1-0504 through pc1-0588. philips warned that when the affected systems are switched off or when the tube arm is parked into its designated parking position (x-ray generator switch off), a radiation pulse (50 kv, 2.5 μgy) is inadvertently generated. this occurs on a small number of systems with a particular electronic component on the controller board. according to philips, there is a potential that the radiation from this extra x-ray pulse might reach a person in the vicinity of the system, resulting in unintended exposure. this extra radiation may also cause artifacts on x-ray images, if a cassette was in the path of the radiation. philips supplemented that the controller board of the affected systems will be updated later. meanwhile, the affected users are advised to completely close the shutters of the collimator before switching off the system and before bringing the tube assembly to its parking position. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted 31 may 2012.